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BEYOND study is designed to generate the first real-world data from GCC countries on the patient characteristics, treatment patterns, survival outcomes, and safety of T-DXd in patients with HRpositive,HER2-low or HER2-ultralow mBC previously treated with ET. The evidence generated will help to optimise treatment strategies, inform clinical guidelines, and ultimately improve outcomes for patients with mBC across the region.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TDxd | Drug | Observing Trastuzumab Deruxtecan in Patients with HR positive, HER2-low or Ultra-low Metastatic Breast Cancer Previously Treated with Endocrine Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| real-world progression-free survival | To describe the real-world progression-free survival (rwPFS) of T-DXd in patients with HR-positive, HER2-low or HER2-ultralow mBC who initiated T-DXd after progression on ET in the GCC countries | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| safety profile | To assess the safety profile (in terms of incidence and severity of adverse events [AEs], particularly treatment-emergent AEs (TEAEs) and those of special interest) and reasons for treatment discontinuation during the period with active treatment on T-DXd in the GCC countries. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
Female patients aged ≥18 years old at the time of T-DXd initiation
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The study population will consist of adult (age ≥ 18 years old at the date of T-DXd initiation) female patients with a confirmed diagnosis of HR-positive, HER2-low (defined as immunohistochemistry [IHC] 1+ or IHC 2+/In situ hybridization [ISH]-) or HER2-ultralow (IHC 0 with membrane staining) mBC that has progressed on one or more ET in the metastatic setting and initiated T-DXd up to 30 days before the index date.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Abu Dhabi | United Arab Emirates | ||||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
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| baseline patient characteristics |
To assess the baseline patient characteristics and clinical presentation of patients with HR-positive, HER2-low or HER2-ultralow mBC who initiated T-DXd after progression on ET in the GCC countries. |
| 18 months |
| T-DXd treatment patterns | To describe the T-DXd treatment patterns and the lines of ET prior to T-DXd in patients with HR-positive, HER2-low or HER2-ultralow mBC in the GCC countries. | 18 months |
| real-world time to next treatment (TTNT) | To describe the real-world time to next treatment (TTNT) of T-DXd in patients with HR-positive, HER2-low or HER2-ultralow mBC who initiated T-DXd after progression on ET in the GCC countries | 18 months |
| Al Ain City |
| United Arab Emirates |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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